MAUDE Adverse Event Report: NOVOCURE GmbH Optune Gio

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 52-year-old male patient with newly diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6) 2024.On (b)(6) 2026, the patient's spouse informed novocure that the patient had temporarily discontinued optune gio therapy on (b)(6) 2026, due to non-healing scalp lesions.The spouse stated that the infusion therapy was preventing the patient's scalp from adequately recovering and healing.Photographs provided showed both the left and right sides of the patient's scalp.Multiple moderately erythematous ulcerations and lesions were noted on the superior and left lateral scalp.An escharred ulceration was observed on the left scalp above the surgical resection site.Additionally, a small wound dehiscence with yellow exudate was present along the surgical incision.Multiple attempts were made to contact the prescribing physician for further information; however, no response has been received to date.
Additional Manufacturer Narrative
Based on the available information, the contribution of the array placement to the wound dehiscence that might lead to a serious event, requiring medical and/or surgical intervention cannot be ruled out.Wound dehiscence is an expected event with optune gio device use (ef-11 0% and <1% ef-14 optune arm).Contributing factors for wound dehiscence in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications, source bevacizumab prescribing information), prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease and prior surgery affecting skin integrity.

• Brand Name: Optune Gio
• Common Device Name: Optune Gio
• Manufacturer (Section D): NOVOCURE GmbH; 21 neuhofstrasse; baar 6340 ; SZ 6340
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50767571
• Report Number: 3010457505-2026-00859
• Device Sequence Number: 13110371
• Product Code: NZK
• UDI-Device Identifier: 07290107986427
• UDI-Public: (01)07290107986427(11)180225
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100034/S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male